Regeneron won’t pursue accelerated OK for ovarian cancer treatment

Tarrytown-based Regeneron Pharmaceuticals Inc., which has its manufacturing plant in East Greenbush, said its use of Aflibercept (VEGF Trap) in advanced ovarian cancer patients lengthened the time between procedures to remove fluids in the abdominal cavity.

The company is working with sanofi-aventis on development of the cancer drug.

Mean time to the first repeat of the procedure following the first baseline procedure was 55 days, compared to 23 days for patients who received a placebo, Regeneron announced today. There was no significant difference in death rates between the two groups of late-stage cancer patients, however.

The Phase 2 trial involved 55 patients.

“Given the small number of patients enrolled in this study and the fragile health status of these advanced ovarian cancer patients, who had a median survival of only about three to four months, it is difficult to definitively assess the overall clinical benefit that might be derived from treatment in the real-world clinical practice setting,” said Dr. George D. Yancopoulos, president of Regeneron Research Laboratories. “Therefore, we and sanofi-aventis have decided not to submit these Phase 2 data for accelerated approval in symptomatic malignant ascites (accumulation of fluid in the abdomen).

“We will focus our efforts on completing the current Phase 3 program which combines aflibercept with standard chemotherapy regimens for the treatment of earlier stage metastatic colorectal, non-small cell lung, pancreatic, and prostate cancers, which should begin delivering data in 2010.”